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Archive for the tag “relapsing-remitting MS”

Study Questions Influence of High-Salt Diet on MS

SUMMARY

  • Some recent studies have suggested that high intake of salt in the diet might influence MS disease activity and progression, but other studies have not confirmed that link.
  • In work partly funded by the National MS Society, researchers took advantage of data accumulated from a previous clinical trial involving 465 people with possible early signs of MS (CIS) whose salt levels in urine were measured over the course of 5 years.
  • They found no connection between salt intake and MS activity.
  • The study, “Sodium Intake and Multiple Sclerosis Activity and Progression in BENEFIT,” was published in the July 2017 issue of the Annals of Neurology (2017;82:20-29).
  • Although this study does not support a link between high-salt diets and MS disease activity, research suggests that most Americans eat more salt than is recommended by federal guidelines. Reducing dietary salt is considered by most to be beneficial to the heart and circulatory system.

DETAILS
Background: Several recent studies have suggested that dietary salt (sodium chloride) could potentially influence MS disease activity and progression. For example, one study of 70 people with relapsing-remitting MS, who were followed for two years, found that higher levels of salt measured in urine samples were associated with a higher rate of relapses and larger brain MRI lesions. In addition, mice fed a high-salt diet developed a more aggressive course of EAE, a laboratory model of MS. But two studies in pediatric MS did not find a relationship between self-reported salt intake and MS risk or relapse rates. Resolving this question is important because it offers the possibility that reducing salt intake might improve a person’s overall health and their course of MS.

This Study: In work partly funded by the National MS Society, researchers set out to determine if a high-salt diet is associated with faster conversion from a first neurologic episode (known as clinically isolated syndrome or CIS) to a diagnosis of definite multiple sclerosis, or with MS disease activity. Kathryn C. Fitzgerald, ScD (Johns Hopkins School of Medicine), Alberto Ascherio, MD, DrPH (Harvard T. H. Chan School of Public Health) and colleagues took advantage of data accumulated from a previous clinical trial involving 465 participants who participated in a trial called BENEFIT (Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment) over 5 years. The trial compared benefits of giving interferon to individuals with CIS early versus later. Each person provided an average of 14 urine samples throughout the five-year follow-up. The researchers estimated average long-term sodium intake from the multiple urine samples, adjusting for age, sex, height, weight, where participants lived, and many other variables.

Results: Researchers found that neither average nor high urine sodium levels were associated with conversion to definite MS. They also weren’t associated with new MRI lesions at any point in the five years, relapse rates, or progression of disability. These results suggest that high sodium intake does not play a major role in influencing MS disease course or activity in people treated with interferon, at least in the early stages of the disease.

While the study has several strengths, including its length, large sample size, and systematic collection of data, it has limitations: BENEFIT participants were treated nearly uniformly with interferon, and the results may not apply to people on other therapies or no therapy. In addition, participants in the BENEFIT trial were primarily Caucasian and resided in Europe and Canada, and it isn’t known if similar results would apply to other populations and ethnicities. The results also don’t answer the question of whether salt intake affects the risk of developing MS in the first place.

The study, “Sodium Intake and Multiple Sclerosis Activity and Progression in BENEFIT,” was published in the July 2017 issue of the Annals of Neurology (2017;82:20-29).

Comment: Although this study does not support a link between high-salt intake and MS disease activity, research suggests that most Americans eat more salt than is recommended by federal guidelines. Even in the absence of direct evidence that MS immune activity is influenced by salt, reducing dietary salt is considered by most to be beneficial to the heart and circulatory system.

Read More: Diet, along with exercise, cognitive health, and other healthy behaviors can make a big difference to how you feel as you deal with MS. Learn more about living well with MS

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Positive Results from Study of Bone Marrow-Derived Stem Cells in People with Aggressive, Relapsing MS

Summary

  • Researchers in Canada have published results of a long-term trial of an individuals’ own (autologous) hematopoietic (blood cell-producing) stem cell transplantation. The study involved 24 people with aggressive relapsing-remitting MS whose disease was not controlled with available therapies.
  • Three years after the procedure, 70% remained free of disease activity, with no relapses, no new MRI-detected inflammatory brain lesions, and no signs of progression.
  • None of the surviving participants, who were followed for 4 to 13 years after the procedure, experienced clinical relapses or required MS disease-modifying therapies to control their disease, and 40% experienced reductions in disability.
  • One of the participants died and another required intensive hospital care for liver complications. All participants developed fevers, which were frequently associated with infections, and other toxicities.
  • Additional research is focusing on figuring out who might benefit from this procedure and how to reduce its risks.

“These results suggest that aggressive MS may be stopped with an effective but risky procedure, for a subset of people,” said Dr. Bruce Bebo, Executive Vice President, Research, at the National MS Society. “Additional research by investigators around the world is focusing on figuring out who might benefit from this procedure and how to reduce its risks, which can include death.”

Details
Background: An experimental procedure that has been explored for several years in MS is called “autologous hematopoietic (blood cell-producing) stem cell transplantation” – or HSCT. This procedure has been used in attempts to “reboot” the immune system, which launches attacks on the brain and spinal cord in people with MS.

In HSCT, the stem cells (derived from a person’s own bone marrow or blood) are stored, and the rest of the individual’s immune cells are depleted by chemotherapy. Then the stored stem cells are reintroduced by infusion into the vein. The new stem cells migrate to the bone marrow and over time produce new blood cells, including immune cells. The goal of this currently experimental procedure is to establish a new immune system that no longer recognizes myelin and other nervous system tissue as dangerous. In theory, this should stop the attacks that lead to tissue damage and disability.

There are a number of laboratories around the world testing variations of HSCT for the treatment of autoimmune diseases, including MS. Preliminary findings suggest this is a promising, but potentially risky strategy for the treatment of MS.

The Study: Drs. Harold Atkins, Mark Freedman and team at the Ottawa Hospital, University of Ottawa and other institutions in Canada conducted a Phase 2 trial of HSCT that involved 24 people with aggressive relapsing-remitting MS whose disease was not controlled with available therapies. No control group was used which would have enabled comparison against the results found in the treatment group. The procedure used by this group included complete destruction of bone marrow cells and an additional step that enriched the transplanted cells for stem cells.

Results – Safety: One of the participants died of transplantation-related complications that caused liver failure and another required intensive hospital care for liver complications. The treatment regimen was modified over the course of the study to reduce toxicity, but all participants still developed fevers, which were frequently associated with infections.

Results – Effectiveness: Three years after the procedure, 70% of the participants remained free of disease activity, meaning they had no relapses, no new MRI-detected inflammatory brain lesions, and no signs of progression. The remaining 30% experienced progression of disability. In addition, for the entire follow-up period ranging from 4 to 13 years after the procedure, of the 23 survivors:

  • None experienced clinical relapse, had new active inflammatory MRI brain lesions, or required MS disease-modifying therapies to control their disease.
  • The average rate of brain atrophy (shrinkage), a measure that has been linked to MS progression, returned to levels associated with normal aging.
  • 40 percent experienced some lasting reversal of disability such as vision loss, muscle weakness and balance problems.
  • Some were able to return to work or school.

The results were published online on June 9, 2016 in The Lancet.  Major funding for the study came from the MS Society of Canada and its affiliated Multiple Sclerosis Scientific Research Foundation.

Next Steps: Rigorous clinical trials of stem cell therapies are needed to determine their safety and effectiveness in people with MS. Trials of this and other stem cell therapy approaches are taking place in Canada, the United States, Europe and elsewhere. To help explore the potential of stem cell therapy, in November 2015, the International Conference on Cell-Based Therapy for Multiple Sclerosis was convened in Lisbon, Portugal under the auspices of the International Advisory Committee on Clinical Trials in MS (a group jointly sponsored by the National MS Society and the European Committee for Treatment and Research in Multiple Sclerosis). Seventy leading researchers and clinicians conferred on clinical trials needed to provide answers about which types of cells, which route of delivery, and which types and stages of disease, would be the most promising approach for treating MS. Read more about this meeting

Read more about stem cells and MS

MS Trial Alert: Investigators Nationwide Recruiting People with MS for Phase I Study to Determine Safety of Experimental Antibody in Treating Relapse

Summary: Investigators nationwide are recruiting 30 people with MS for a phase I study to determine the safety and tolerability of rHIgM22, an experimental antibody. Participants may remain on their current therapy throughout the study. The study is enrolling participants experiencing a clinical acute relapse (new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days) and with at least one new, active lesion (damaged area) on MRI scans. The study is funded by Acorda Therapeutics, Inc.

Rationale: Although the body repairs some damage to nerve-insulating myelin that occurs in MS, this repair is insufficient. One strategy under study is to stimulate the body’s own internal repair capabilities. With funding from the Hilton Foundation, NIH, the National MS Society and others, Moses Rodriguez, MD, and colleagues (Mayo Clinic Foundation) identified a human antibody – rHIgM22 – that targets and attaches to myelin-making cells. When given to mice with an experimental MS-like disease, rHIgM22 promotes myelin repair. This antibody was well tolerated in another phase I study (trial NCT01803867, as listed on clinicaltrials.gov) in 55 people with all types of MS. (Abstract #P4.339, Annual Meeting of the American Academy of Neurology 2015)

Eligibility and Details: Men and women between the ages of 18 and 70 with a diagnosis of MS are eligible. The study is enrolling participants with a clinical acute relapse; an MRI will be performed to confirm that there is an active lesion (damaged area). There are detailed exclusion criteria related to laboratory, cardiac, immune and other factors. For more information on these criteria, please use the contact information below.

Participants will remain on their current therapy throughout the study. Upon entering the study with an acute relapse, subjects will receive high-dose oral steroids for five days, a standard treatment for an acute relapse. Following completion of the oral steroids for the acute relapse the subjects will receive either a single dose of rHIgM22 or placebo.

Investigators are testing 2 dose levels. For each dose, 10 participants are being randomly assigned to receive active treatment (rHIgM22) and 5 are being randomly assigned to receive inactive placebo, both via a single intravenous infusion. Blood samples will be collected from participants before and at specified times for up to 48 hours after dosing, so participants must agree to remain in the hospital for that time. Participants are being followed for 180 days after dosing, which includes return visits to the clinic and MRI scans.

The primary outcome of the study is to determine the safety and tolerability of rHIgM22 in people with MS. Adverse events are being monitored throughout the study. The investigators will also evaluate how this experimental treatment is absorbed in the body, and how the immune and nervous systems react to it. Phase I studies are the first of three stages of clinical trials that determine whether an exploratory treatment is safe and beneficial.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact Kevin Cronin, Manager Corporate Communications, kcronin@acorda.com, 914-326-5279, or visit the trial’s listing on clinicaltrials.gov to find the site nearest you.

Sites are recruiting in the following cities:

Aurora, CO
Centennial, CO (Denver metro-area)
Dallas, TX
Indianapolis, IN
Long Beach, CA
Rochester, NY
Sacramento, CA
Saint Louis, MO
San Francisco, CA
Seattle, WA
Stanford, CA
Teaneck, NJ (NY metro area)

Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).

Study Shows MS Progresses Faster in Those Who Continue to Smoke

Summary
A new study involving people with MS who smoked cigarettes suggests that those who continued to smoke after receiving an MS diagnosis were quicker to reach the secondary-progressive phase of MS than those who quit after diagnosis.
Those who continued to smoke converted to secondary-progressive MS at a median age of 48, while those who quit smoking within the year after MS diagnosis progressed at a median age of 56.
This adds to evidence that smoking may speed progression of MS, and offers new evidence that quitting smoking after MS diagnosis may slow progression.
The team (Ryan Ramanujam, PhD, Jan Hillert, MD, PhD, and colleagues at Karolinska University Hospital Solna, Stockholm, Sweden) has published results in JAMA Neurology (Published online September 8, 2015). The full paper is available free of charge.

Background: In most people, MS begins with a relapsing-remitting course with defined attacks of worsening neurologic function, followed by periods of partial or complete recovery. Most people eventually transition to secondary-progressive MS, where the disease begins to progress or worsen more steadily, with or without relapses. The factors that determine if or when a person may transition to secondary-progressive MS are not fully understood. Some studies have found that smoking is related to disease progression, and that MS disability progresses more quickly in smokers, but the impact of quitting after diagnosis had not been thoroughly determined.

The Study: Investigators identified 728 people with MS who smoked at the time of MS diagnosis and were enrolled in the large Genes and Environment in MS Study in Sweden. Of these, 332 were classified as “continuers” who smoked at least one cigarette per day continuously from the year after diagnosis and 118 were considered “quitters,” who had stopped smoking within the year after diagnosis. A group of 278 were “intermittent smokers” but were not included in the final evaluation.

The main focus of the study was to determine how smoking was related to conversion to secondary-progressive MS, which occurred in 216 people. The researchers found that each year of smoking after diagnosis accelerated the time to conversion to secondary-progressive MS by 4.7%. Continuers progressed to secondary-progressive MS faster (at a median age of 48) compared with quitters (age 56).

Results were published in JAMA Neurology (Published online September 08, 2015). The full paper is available free of charge.

Comment: This is an important study that adds to evidence that smoking speeds progression of MS, and offers new evidence that quitting smoking after MS diagnosis may slow progression. In an accompanying editorial, Drs. Myla D. Goldman (University of Virginia, Charlottesville) and Olaf Stüve (University of Texas Southwestern Medical Center at Dallas) comment that this may be the first evidence that quitting smoking can delay conversion to secondary-progressive MS. “Therefore, even after MS diagnosis, smoking is a risk factor worth modifying,” they write.

The National Institutes of Health provides resources to help quit smoking: visit smokefree.gov or call 1-800-QUITNOW (1-800-784-8669).

Recent Update to Gilenya Prescribing Information

 A recent warning and precaution has been added to the prescribing information for Gilenya® (fingolimod, Novartis AG), an oral disease-modifying therapy for relapsing forms of multiple sclerosis. The warning adds Cryptococcal fungal infections to the list of possible infections for which people taking Gilenya are at increased risk. Anyone receiving this or other medications that can compromise immune system function should promptly report any new or worsening symptoms – both MS-like symptoms and other symptoms – to their neurologist.
The updated prescribing information approved by the U.S. Food and Drug Administration states that there have been cases of cryptococcal infections, including cryptococcal meningitis, reported in people taking Gilenya. Individuals and their healthcare providers should be alert to symptoms and signs that could indicate cryptococcal meningitis. This rare condition can be managed if it is diagnosed and treated promptly.
Cryptococcus is a type of fungus that is commonly found in the soil throughout the world. The fungus becomes airborne and people may breathe in microscopic amounts. Most people never get sick from breathing the fungus; cryptococcus typically infects people who have compromised immune system function – which can occur from illness, or due to the effect of some medications, including some medications that are prescribed to treat MS.
Infection with cryptococcus is uncommon, but it can be very serious and even lead to death if untreated. It is important to recognize the infection early and treat it promptly. The usual sites for cryptococcal infections are the lungs and the central nervous system (brain and spinal cord).

Symptoms of a lung infection may include:
• cough
• chest discomfort
• shortness of breath
• low grade fever
• weight loss
• a general sense of feeling unwell
Central nervous system infections may produce numerous symptoms including:
• headache
• confusion
• stiff neck
• light sensitivity
• mild fever
• nausea and vomiting
• vision change
• unsteady walking
• change in speech
• seizures
• abnormal muscle movements
The increased risk of many types of infection is also pertinent to people with MS who are receiving other powerful immune modifying or suppressing therapies. Therefore, it is important when receiving medications that can compromise immune system function to promptly report any new or worsening symptoms – both MS-like symptoms and other symptoms, such as those mentioned above – to your neurologist. It is also important to speak to with your doctor before making any changes to your medications.

Download the updated prescribing information (.pdf)

Download the updated medication guide for patients (.pdf)

Anxiety and MS

It is not often that I feel “lucky” as a person with MS, however, I do feel extremely fortunate to have never had to endure a mood disorder as a symptom of my disease. For a very brief time when I was younger, I suffered with periodic depression as a symptom of premenstrual syndrome, and that was enough to give me the tiniest glimpse into the horror of a mood disorder. When I was diagnosed with MS and learned about the variety of symptoms that I could encounter, my fear of depression and cognitive dysfunction far outweighed my fear of losing mobility.

Since depression is a well-known symptom of MS, I was shocked to learn at the 2014 ACTRIMS-ECTRIMS Meeting that more people with MS have an anxiety disorder than have depression. A study of 7786 adults with MS showed that 54.1% had “excessive symptoms of anxiety,” while 46.9% had “excessive symptoms of depression.”

It turns out that the prevalence of anxiety disorders in people with MS is roughly three times the prevalence of these disorders in the general population. More specifically, statistics show that among people with MS:

  • 18.6% have general anxiety disorder at any time (compared to 5.1% of people in the general population)
  • 10.0% have panic disorder (vs. 3.5% in general population)
  • 8.6% have obsessive compulsive disorder (OCD) (vs. 2.5% in the general population)
  • Social anxiety is also higher in people with MS than the general population.

In addition, more women with relapsing-remitting MS (RRMS) than men with RRMS are affected by anxiety disorders. People with secondary progressive MS were more likely to have symptoms of anxiety than those with other disease types.

Anxiety has received only a fraction of the attention depression has received as a disorder overall. However, it has been shown that anxiety in combination with depression, rather than anxiety or depression alone, are associated with increased thoughts of self-harm and more social problems. Despite the high prevalence in people with MS, as well as the potential risks when anxiety is combined with depression, the treatment or management of anxiety in MS has not been specifically studied. In my opinion, this is a problem, since MS symptoms can be made worse by the side effects of antianxiety drugs, which include: drowsiness and lack of energy, clumsiness, impaired thinking and memory loss, and slurred speech.

Another challenging factor is the difficulty faced by neurologists around diagnosing this disorder in their patients. There are a couple of reasons for this. People who are newly diagnosed with MS often exhibit symptoms of anxiety that may be transitory as they adjust to their diagnosis. More challenging is the overlap of symptoms between anxiety and MS. All of these extremely common MS symptoms are also symptoms of anxiety: pain, tremors, “buzzing” in their limbs, numbness, problems swallowing, tightness around the rib cage, sexual dysfunction and weak arms and legs.

What I would like to emphasize for anyone who is experiencing symptoms of an anxiety disorder or depression is that it is NOT your fault. People with these disorders can no more “pull themselves out of it” by “counting their blessings” or “looking on the bright side” than people in wheelchairs can get up and walk at will. If you are feeling any of the symptoms of these disorders, please seek professional help, preferably from a psychiatrist or other mental health professional who has experience treating people with MS.

Note: One very specific form of anxiety that was mentioned in the session was injection phobia, brought about when people have anxiety around self-injecting their MS disease modifying therapies. There has been some success in alleviating this using cognitive behavioral therapy. It is important to address injection phobia as soon as possible, as this reluctance to self-inject can lead to problems with adherence.

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